UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025268 |
|---|---|
| Receipt number | R000029047 |
| Scientific Title | Analyses of eye movement and motor functions with the improvement of writing skills |
| Date of disclosure of the study information | 2016/12/16 |
| Last modified on | 2019/06/17 10:09:39 |
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Basic information
Public title
Analyses of eye movement and motor functions with the improvement of writing skills
Acronym
Analyses of eye movement and motor functions with the improvement of writing skills
Scientific Title
Analyses of eye movement and motor functions with the improvement of writing skills
Scientific Title:Acronym
Analyses of eye movement and motor functions with the improvement of writing skills
Region
| Japan |
Condition
Condition
Typically developing adults
Typically developing students
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we first analyze the eye movement patterns and motor functioning during handwriting for typically developing students and adults by using an eye-tracker. We also examine whether copying the segment by sequential stimulus presentation is effective for our participants to improve their writing skills and develop their eye movement patterns and motor functioning.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Writing time
- Standard scores of the Beery VMI-6
- Mean number of fixation
- Mean fixation duration
- Percentage of total fixation duration in writing time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Students are instructed to copy the segments of a sentence that are presented in a temporal sequence. Training will last for about 15 minutes a day, up to a maximum of 4 days, until students are able to fluently copy the sentence in a target time.
Interventions/Control_2
We do not conduct any copying training for typically developing adults.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 11 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Regardless of the diagnosis of developmental disabilities, all participants should be enrolled in a mainstream elementary school, junior high school, and university.
Key exclusion criteria
- Persons who cannot understand and agree on the purpose and method of this study
- Persons whose mother language is not Japanese
- Persons who are difficult to visit our lab for one to five times
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Mikimasa |
| Middle name | |
| Last name | Omori |
Organization
Showa Women's University
Division name
Department of Psychology
Zip code
154-8553
Address
1-7-57, Taishido, Setagaya-ku, Tokyo, 154-8553
TEL
03-3411-5094
mikkiomori@swu.ac.jp
Public contact
Name of contact person
| 1st name | Mikimasa |
| Middle name | |
| Last name | Omori |
Organization
Showa Women's University
Division name
Department of Psychology
Zip code
154-8553
Address
1-7-57, Taishido, Setagaya-ku, Tokyo, 154-8553
TEL
03-3411-5094
Homepage URL
mikkiomori@swu.ac.jp
Sponsor or person
Institute
Showa Women's University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Show Women's University IRB
Address
1-7-57, Taishido, Setagaya-ku, Tokyo, 154-8553
Tel
0334117351
kenkyu@swu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 14 | Day |
Last modified on
| 2019 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029047
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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